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The GRT LITE Model PRO-8A is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for:

• -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
• -- Adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS).

The Model PRO-8A is a hand-held, non-invasive, pain therapy system which utilizes four nonheating light emitting diodes (LED) consisting of two visible LED's and two infrared LED's in one system. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved. The system consists of a basic hand-held, battery operated, control unit with the four LED's emitting light through a special red acrylic lens which does not absorb any light transmission. The visible LEDs operate at a measured wavelength of 628nm (±5%) and the infrared LEDs operate at a measured wavelength of 850nm (±5%).

The provided document (K050668) describes a 510(k) premarket notification for the GRT LITE Model PRO-8A Light Therapy System. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study proving the device meets specific acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information typically requested about acceptance criteria and a study proving device performance (as in a clinical trial with specific endpoints and statistical analysis) is not applicable in this context.

Instead, the document focuses on demonstrating that the GRT LITE Model PRO-8A has the same intended use and similar technological characteristics as several already approved predicate devices.

Here's a breakdown of the available information regarding the device's characteristics and how its equivalence is established:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, there isn't a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial. Instead, the "performance" is assessed against the characteristics of the predicate devices.

• Adjunctive use for temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS). | - Adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
• Adjunctive use for temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS). |
  | Wavelength (Visible LEDs) | Clinically accepted therapeutic wavelengths in predicate devices | 628nm (±5%) |
  | Wavelength (Infrared LEDs) | Clinically accepted therapeutic wavelengths in predicate devices | 850nm (±5%) |
  | Power Output | Conforms to specifications of predicate devices | Conforms to specifications of predicate devices (implicitly, as it provides the same treatment benefits) |
  | Frequency (Pulsed/Continuous) | Conforms to specifications of predicate devices | Offers six different operating modes with specific operating frequencies (pulsed or continuous) |
  | Type of Device | Pulsed therapeutic light therapy systems, non-heating infrared lamps | Hand-held, non-invasive, pain therapy system utilizing four non-heating LEDs (two visible, two infrared) |
  | Safety and Standards Compliance | Complies with relevant FDA regulations and electrical safety standards | Complies with:
• 21CFR - Subchapter J - Part 1010
• FCC Standard - 47CFR Part 15B
• All Electrical Components Utilized Are UL® Approved |

2. Sample Size for the Test Set and Data Provenance:

• Not Applicable. This submission does not involve a clinical study with a "test set" of patients in the typical sense. Equivalence is established based on technological characteristics and intended use compared to previously approved devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. No ground truth for a clinical test set was established as part of this 510(k) submission. The FDA reviewers are the "experts" assessing the information provided.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This device is a light therapy system, not an AI-based diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device is a physical light therapy system, not an algorithm. Performance is assessed based on its physical characteristics and operational modes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" in this context is the FDA's regulatory acceptance, based on previous approvals of similar devices (the predicates). The submission aims to demonstrate that the GRT LITE Model PRO-8A conforms to the performance specifications and clinical parameters already approved for these predicate devices.

8. The sample size for the training set:

• Not Applicable. No training set for an algorithm is involved.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

Summary of the "Study" (Equivalence Demonstration):

The "study" in this 510(k) submission is a comparison and verification process to demonstrate substantial equivalence to predicate devices:

• Methodology: The manufacturer compared the GRT LITE Model PRO-8A's intended use and technical characteristics (wavelength, power output, frequency) to those of four identified predicate light therapy systems (Tuco Erchonia PL3000, Excalibur System, Microlight 830 Laser, Acculaser Pro LLLT Device).
• Testing: Functional performance, electrical safety, and component specification verification were conducted. This included an "eight-stage manufacturing testing and verification GRT Solutions, Inc. procedure protocol" tracked by serial number. This manufacturing testing verified correct diode performance, operating mode parameters, power output, and total operating time.
• Conclusion: The manufacturer concluded that the GRT LITE Model PRO-8A has the same intended use and similar functional and performance characteristics as the predicate devices, meeting or exceeding required design, testing, and labeling standards, and raising no new regulatory, safety, and/or clinical efficacy issues. The FDA concurred with this assessment, finding the device substantially equivalent.

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The LAPEX-2000 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The LAPEX-2000 is a low level laser therapy device.

This 510(k) submission (K034009) for the LAPEX-2000 low-level laser therapy device asserts substantial equivalence to predicate devices rather than providing a new clinical study with defined acceptance criteria and performance metrics. Therefore, many of the requested details are not available.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the submission. The submission relies on demonstrating substantial equivalence to predicate devices, implying that if it is equivalent, it meets the inherent safety and effectiveness standards of those previously cleared devices. There are no explicit acceptance criteria or reported performance metrics (like sensitivity, specificity, or improvement effect size) for the LAPEX-2000 itself in this document.

The comparison table provided focuses on technical specifications and intended use to show similarity to predicate devices:

The conclusion states that the device is "as safe and effective as the predicate device" based on "bench, electrical safety, EMC, and user testing data," but the details of this testing (acceptance criteria, performance results) are not elaborated upon.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. This submission does not include a clinical study with a "test set" in the context of device performance metrics. The mention of "user testing" is too vague to determine sample size or data provenance. The focus is on demonstrating technical equivalence and shared intended use with existing devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/Not provided. As there is no clinical study with a test set requiring ground truth establishment, this information is not relevant to this submission type.

4. Adjudication Method for the Test Set

Not applicable/Not provided. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study was not conducted or reported in this submission. The submission does not discuss human reader performance or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a therapeutic laser, not an algorithm, so a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

Not applicable/Not provided. For a substantial equivalence claim, the "ground truth" is largely established by the regulatory clearance of the predicate devices for their indicated uses and the technical similarity of the new device. No specific ground truth type (like pathology or outcomes data) for a novel clinical study is detailed for the LAPEX-2000.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is hardware, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided. This information is not relevant for this type of device and submission.

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The TriLumina Therapeutic Laser System is a non-heating infrared lamp and is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

The TriLumina Therapeutic Laser is an innovative, safe, easy to use, hand-held, battery operated, non-invasive, athermal low energy infrared laser device. The TriLumina Therapeutic Laser contains three gallium-aluminum-arsenide continuous wave diodes operating in the near infrared at a wavelength of 830 nanometers and a visible red light emitting diode is used as a quide beam. The device has a power output of 30 milliwatts for each GaAlAs diode with a noncollimating beam of dimensions of approximately 1 by 3 millimeters at the lens. The Laser has an "On / Off" switch to control the power to the device and two pressure switches that when pressed energize the laser diodes. A timer automatically times the 30 second activation cycle and the delivery of 3 Joules of energy.

The provided text is a 510(k) premarket notification summary for the TriLumina Therapeutic Laser System. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's technical characteristics and intended use.

However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its performance in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome. Instead, it relies on the substantial equivalence principle, comparing its technical specifications and intended use to already cleared devices.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions regarding sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies. These types of studies would typically be conducted to prove clinical efficacy, which is often not required for 510(k) submissions that demonstrate substantial equivalence to previously cleared devices.

The document essentially states:

• Intended Use: Adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.
• Mechanism: Non-heating infrared lamp (low energy therapeutic laser) using gallium-aluminum-arsenide continuous wave diodes at 830 nm.
• Basis for Clearance: Substantial equivalence to predicate devices (MicroLight 830 Laser System, Acculaser Pro Low Level Laser System, MedX LCS System) that are also low-level therapeutic lasers.

Without a clinical study described in the provided text, I cannot generate the detailed acceptance criteria and study information you requested.

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